Mass Spectroscopy for Clinical Laboratory Analysis

  • November 2011
  • -
  • TriMark Publications
  • -
  • 165 pages

Mass spectroscopy is a clinical laboratory analysis technique used in determining the basic composition and structure of a sample or molecule. The process involves bending a charged beam of vaporized material using an electric and/or magnetic field and then plotting a spectrum of how the sample's ions are deflected. Mass spectroscopy assays based on well-documented techniques such as time-of-flight, liquid chromatography/tandem, liquid chromatography, gas chromatography-quadrupole and others have gained wide acceptance in the clinical laboratory due to their accuracy, speed and sensitivity compared to traditional analytical drug detection techniques. This TriMark Publications report provides a detailed analysis of the mass spectroscopy drug testing market, including size, growth, technology platforms, clinical applications, new instrumentation, industry trends and the internal structure of the sector. The mass spectroscopy market remains the fastest-growing segment of the diagnostics analytical instruments market.

Highly-attractive clinical growth areas covered in this study include: disease markers; molecular diagnostics; infectious disease; toxicology; inborn errors in metabolism; metabolomics; proteins and peptides; small molecule analytes (vitamins, steroids, thyroid, etc.); tobacco exposure; chemical warfare agents; tissue analysis by MALDI; clinical chemistry/toxicology; microbiology/virology; proteomic, metabolomic and tissue histology laboratories; high-end MS; and food testing. Also provided in this review is a thorough analysis of the companies known to be marketing, manufacturing or developing mass spectroscopy products in the U.S. and worldwide, as well as detailed tables, charts and figures with past and projected data analyzed by geographic region with a focus on the U.S., Europe and Japan, the world's three largest mass spectroscopy markets.

Table Of Contents

TABLE OF CONTENTS

1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 10
1.3 Scope of the Report 11
1.4 Objectives 11
1.5 Methodology 12
1.6 Executive Summary 13

2. Introduction to Mass Spectroscopy for Clinical Laboratory Testing 17
2.1 Mass Spectroscopy Testing and Opportunities in the Clinical Laboratory
Sector 17
2.2 Overview of Laboratory Mass Spectroscopy Instrumentation 21
2.2.1 Clinical Applications of Mass Spectrometry 22
2.2.1.1 Therapeutic Drug Monitoring 22
2.2.1.2 Metabolic Diseases 22
2.2.1.3 Endocrinology 23
2.2.1.4 Clinical Toxicology 23
2.2.1.5 Proteomics 24
2.2.1.6 Biomarkers 24
2.3 Opportunities in Mass Spectroscopy and Clinical Diagnostics 24
2.4 Development of Mass Spectroscopy Testing Markets 25
2.5 Mass Spectrometry 26
2.5.1 Overview of Mass Spectrometry 26
2.5.2 Sample Introduction Techniques 27
2.5.3 Ionization Source 28
2.5.3.1 Electrospray Ionization 29
2.5.3.2 Electron Ionization 30
2.5.3.3 Matrix-Assisted Laser Desorption/Ionization (MALDI) 31
2.5.4 Mass Analyzers 32
2.5.4.1 Quadrupoles 35
2.5.4.2 Quadrupole Ion Trap 36
2.5.4.3 Linear Ion Trap 38
2.5.4.4 Quadrupole Time-of-Flight Tandem MS (TOF) 38
2.5.4.5 MALDI with Time-of-Flight Analysis (MALDI-TOF) 39
2.5.4.6 Quadrupole Time-of-Flight MS 40
2.5.4.7 Fourier Transform Mass Spectrometry (FTMS) 41
2.5.5 Ion Detectors 42
2.6 Advances in Mass Spectroscopy Technologies 45
2.6.1 Market Drivers and Restraints 45
2.6.1.1 Market Drivers 45
2.6.1.2 Market Restraints 46
2.6.2 Market and Technology Trends 46
2.6.2.1 Market Trends 46
2.6.2 2 Technology Trends 46
2.6.3 Strategic Recommendations 47

3. Mass Spectroscopy Diagnostics Testing Market 48
3.1 Market Overview 48
3.1.1 Overall Mass Spectroscopy Clinical Laboratory Market Analysis 51
3.2 Mass Spectroscopy Diagnostics Market 62
3.3 Mass Spectroscopy Clinical Testing Platforms 63
3.3.1 Gas Chromatography/Mass Spectrometry (GC/MS) 63
3.3.1.1 Background 63
3.3.1.2 Instruments 64
3.3.1.3 Method Comparisons 65
3.3.1.4 Market Drivers and Restraints 66
3.3.1.4.1 Market Drivers 66
3.3.1.4.2 Market Restraints 66
3.3.1.5 Market and Technology Trends 66
3.3.1.5.1 Market Trends 66
3.3.1.5.2 Technology Trends 66
3.3.1.5.3 Strategic Recommendations 67
3.3.2 Ion Trap and Quadrupole Mass Spectrometers 67
3.3.2.1 Background 67
3.3.2.1.1 Instruments 68
3.3.2.1.2 Method Comparisons 69
3.3.2.1.3 Market Challenges and Strategic Recommendations 69
3.3.2.1.3.1 Market Drivers and Restraints 69
3.3.2.1.3.1.1 Market Drivers 69
3.3.2.1.3.1.2 Market Restraints 70
3.3.2.1.4 Market and Technology Trends 70
3.3.2.1.4.1 Market Trends 70
3.3.2.1.4.2 Technology Trends 70
3.3.2.1.5 Strategic Recommendations 71
3.3.3 Liquid Chromatography/Mass Spectrometry 72
3.3.3.1 Background 72
3.3.3.2 Instruments 73
3.3.3.3 Method Comparisons 74
3.3.3.4 Market Size 75
3.3.3.4.1 Liquid Chromatography/Mass Spectroscopy (LC/MS) Market Size 75
3.3.3.4.1.1 Market Share 75
3.3.3.4.2 Market Challenges and Strategic Recommendations 76
3.3.3.4.2.1 Market Drivers and Restraints 76
3.3.3.4.2.1.1 Market Drivers 76
3.3.3.4.2.1.2 Market Restraints 76
3.3.3.4.3 Market and Technology Trends 77
3.3.3.4.3.1 Market Trends 77
3.3.3.4.3.2 Technology Trends 77
3.3.3.4.4 Strategic Recommendations 77
3.3.4 Ion Mobility and High Definition Mass Spectrometry 78
3.3.4.1 Background 78
3.3.5 Liquid Chromatography Tandem Mass Spectrometry 78
3.3.5.1 Background 78
3.3.6 Time-of-Flight Mass Spectrometry 78
3.3.6.1 Background 78
3.3.7 Orbitrap 79
3.3.7.1 Background 79
3.3.7.2 Instruments 79
3.3.7.3 Method Comparisons 80
3.3.7.4 Market and Technology Trends 81
3.3.7.4.1 Market Trends 81
3.3.7.4.2 Technology Trends 81
3.3.7.4.3 Strategic Recommendations 82
3.3.8 Matrix-Assisted Laser Desorption/Ionization (MALDI) Time-of-Flight Mass
Spectrometry 82
3.3.8.1 Background 82
3.3.9 Inductively coupled Plasma Mass Spectrometry (ICP) 83
3.3.9.1 Background 83
3.3.9.2 Instruments 84
3.3.9.3 Method Comparisons 84
3.3.10 FTMS 85

4. Mass Spectrometry Diagnostic Testing in the Clinical Laboratory 86
4.1 Clinical Laboratory Molecular Tests Using Mass Spectroscopy 86
4.2 Top Mass Spectroscopy Assays 86
4.2.1 Drugs of Abuse 87
4.2.2 Therapeutic Drugs 88
4.2.3 Hormone Analysis 89
4.2.3.1 Vitamin D 90
4.2.3.2 Testosterone and Estradiol 90
4.2.3.3 Other Hormones 91
4.2.4 Newborn Screening 91
4.3 Challenges in Mass Spectrometry Clinical Diagnostic Technologies 93
4.3.1 Market Drivers and Restraints 93
4.3.1.1 Market Drivers 93
4.3.1.2 Market Restraints 94
4.3.2 Market and Technology Trends 94
4.3.2.1 Market Trends 94
4.3.2.2 Technology Trends 94
4.3.3 Strategic Recommendations 94
4.3.4 Cost of Mass Spectroscopy Testing 94
4.3.5 Priorities for Vendors 95
4.3.6 Mass Spectrometers Market Continues to Grow 96
4.4 Mass Spectroscopy Develops Novel Applications 96
4.4.1 Microbiology 96
4.4.2 Metabolomics 97
4.4.3 Cancer Therapy 98
4.4.4 Immunosuppressant Drugs 98
4.4.5 Pain Management Drugs 98
4.5 Paradigm Shift within the Mass Spectrometry Market 98
4.6 Metabolomics 98
4.7 Proteomics 99
4.8 Automated Workstations 101
4.9 Biomarkers 101
4.10 Multiplexing 102
4.11 Use of Mass Spectrometry in Biomarker Discovery 102
4.11.1 Multiple Reaction Monitoring Assays (MRMs) 103
4.11.2 Gel-based Approaches 103
4.11.3 Non-Gel-based Approaches 104
4.11.4 SELDI-TOF MS 104
4.11.5 SELDI and Prognosis 105
4.11.6 SELDI and Treatment Monitoring 105
4.11.7 Limitations of Mass Spectroscopy 105
4.12 Technological Breakthroughs/Innovations 107
4.12.1 Hybrids 107
4.12.2 Integrated and Hybrid-based MS systems 107
4.12.3 LTQ-Velos 108
4.12.4 Applied Biosystems Integrates Two MS technologies 108
4.12.5 Q-TOF-MS Leads 109
4.12.6 Agilent’s Chip LC/MS Systems 109
4.12.7 New Virus Detection System Based on Mass Spectrometry 109
4.12.8 Orbitrap MS System 109
4.12.9 Qual-Quan Mass Spectroscopy 110
4.12.10 SISCAPA 110
4.12.11 SRM/MRM 110
4.12.12 AB Sciex’s iMethod and Cliquid Software 111
4.12.13 Microsaic Mini Mass Specs 113

5. Business Landscape for Mass Spectroscopy for Clinical Labs 114
5.1 Technology and Market Trends 114
5.1.1 Market Trends 114
5.1.2 Technology Trends 114
5.2 Mandamp;A Activity 118
5.3 Partnerships 121
5.4 Competitive Analysis 122
5.4.1 Primary Competitors 122
5.4.2 Industry Challenges and Strategic Recommendations 123
5.4.3 Commercialization of Mass Spectroscopy Products 123
5.5 The Success Achieved by the Mass Spectroscopy Clinical Products 124
5.6 Intellectual Property Rights 124
5.6.1 New Patents 125
5.6.2 Current Patent Disputes 125
5.7 Opportunities and Strategic Recommendations 125
5.7.1 Key Technical Opportunities with Significant Market Appeal in the Mass
Spectroscopy Space in the Next Five Years 125
5.7.2 Developments for Mass Spectroscopy Instrumentation Products 126
5.7.3 Market Penetration Strategies for Clinical Laboratory Testing 126
5.8 Business Models in Mass Spectroscopy Clinical Products 126
5.8.1 Scope of This Section 126
5.8.2 Business Models for Clinical Mass Spectroscopy Markets 127
5.8.2.1 SWOT Comparison of Business Models for Mass Spectrometry Diagnostic
Testing 128
5.8.3 Sales and Marketing Strategies for Clinical Laboratory Tests 131

6. Product Developments/Competitive Landscape 134
6.1 Manufacturers Decisions in the Global Analytical Instrument Industry 134
6.2 Instrument Introductions 134

7. Business Decisions, Strategic Outlook and Recommendations Using Mass
Spectroscopy Technology Platforms in the Clinical Laboratory Testing Space 141
7.1 What are the Key Opportunities for Mass Spectroscopy in Clinical Laboratory
Testing Development and Commercialization? 141
7.2 What are the Current Obstacles for Mass Spectroscopy in Clinical Laboratory
Testing
Implementation? 141
7.3 How Do Business Strategies, Such as those Relating to Acquisition, Drive
Mass Spectroscopy
Strategies? 141
7.4 How Might Novel Clinical Laboratory MS Test Development Lead to Acquisition
or Partnering Strategies and their Implications for Deal Making? 142
7.5 How can Mass Spectroscopy Tests Increase Value in an Associated Drug
Marketing Plan? 142
7.6 Which Types of Clinical Laboratory Testing Should be Developed by Mass
Spectroscopy
Companies? 143
7.7 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 143
7.8 What are the Noteworthy Deals? 143
7.9 Who are the Acquirers? 145
7.10 Who are the Target Companies? 145
7.11 How will Platform Technology Companies Enter the Space? 146
7.12 Will Pharma Integrate with Diagnostics? 146
7.13 How Do Platform Technology Companies Position Themselves for Diagnostic and
Pharma
Development? 146
7.14 Evaluate How Partnering and Mandamp;As will Alter the Competitive Landscape 147
7.15 Predict How FDA Regs will Impact New Diagnostic Tests 147
7.16 How can Big Pharma and Mass Spectroscopy Companies Co-develop Biomarkers in
a Model for Regulatory Acceptance? 148
7.17 How to Maximize Business Development through Biomarker Strategies? 148
7.18 What is the Best Type of Business Model for Developing Genetic Biomarkers
for Clinical
Laboratory? 148
7.19 How Best can Mass Spectroscopy Provide the Most Benefit in Clinical
Laboratory Testing? 149
7.20 What are the Most Innovative Methods in Development of Mass Spectroscopy
Diagnostic
Testing? 150

8. Company Profiles 152
8.1 AB SCIEX 152
8.2 Agilent Technologies 152
8.3 Applied Biosystems/Sciex 153
8.4 bioMerieux 154
8.5 Bruker 154
8.6 Danaher Corporation 158
8.7 Hiden Analytical 159
8.8 JEOL 159
8.9 Konica Minolta 159
8.10 MDS Analytical Technologies 159
8.11 PerkinElmer 159
8.12 Shimadzu Corporation 160
8.13 Spectro 160
8.14 Thermo Fisher Scientific 161
8.15 Varian 164
8.16 Waters Corporation 164


INDEX OF FIGURES

Figure 2.1: Relationship of Mass Spectrometry Testing to Key Areas of Clinical
Diagnosis 19
Figure 2.2: Magnetic or Electrostatic Sector in Mass Spectroscopy 27
Figure 2.3: Triple Quadrupole (Tandem) Mass Spectroscopy 33
Figure 2.4: Time-of-flight Mass Spectroscopy 34
Figure 2.5: Diagram of a Quadrupole MS Analyzer 36
Figure 2.6: Diagram of an Ion Trap MS Analyzer 37
Figure 3.1: Mass Spectroscopy by Testing Type, 2010 50
Figure 3.2: Key Players Market Share in Global Mass Spectroscopy Testing Market
51
Figure 3.3: Mass Spectroscopy World Market and Global Testing for Forensic and
Drug Testing,
2007-2010 52
Figure 3.4: Global Revenue Forecast for Mass Spectroscopy, 2009-2016 53
Figure 3.5: Global Market Revenue Share Forecast for Mass Spectroscopy Testing
Markets by Region,
2010 and 2016 54
Figure 3.6: U.S. Market Revenue Forecast for Mass Spectroscopy, 2009-2016 55
Figure 3.7: European Market Revenue Forecast for Mass Spectroscopy, 2009-2016 56
Figure 3.8: Japanese Market Revenue Forecast for Mass Spectroscopy, 2009-2016 57
Figure 3.9: Global Revenue Forecast for Mass Spectroscopy Forensic and Drug
Testing Market,
2009-2016 58
Figure 3.10: Global Market Revenue Share Forecast for Mass Spectroscopy Forensic
and Drug Testing Markets by Region, 2010 and 2016 58
Figure 3.11: U.S. Market Revenue Forecast for Mass Spectroscopy Forensic and
Drug Testing Market,
2009-2016 59
Figure 3.12: European Market Revenue Forecast for Mass Spectroscopy Forensic and
Drug Testing Market,
2009-2015 60
Figure 3.13: Japanese Market Revenue Forecast for Mass Spectroscopy Forensic and
Drug Testing Market,
2009-2016 61
Figure 3.14: Mass Spectrometry Supplier Market Shares 76
Figure 5.1: Market Growth of MS Clinical Laboratory Tests 132
Figure 8.1: Agilent’s Well Distributed Worldwide Business 153
Figure 8.2: Bruker’s Revenue Stream 157
Figure 8.3: Bruker’s Geographic Distribution 157
Figure 8.4: Thermo Fisher Scientific Laboratory Products Revenue Share 163
Figure 8.5: Thermo Fisher Scientific Biosciences Revenue Shares 163


INDEX OF TABLES

Table 2.1: Mass Spectrometry Utilization in the Clinical and Life Science Space
17
Table 2.2: Mass Spectrometry Tests for Clinical Applications 20
Table 2.3: Emerging Mass Spectrometric Technologies 26
Table 2.4: Advantages of Electrospray Ionization (ESI) 30
Table 2.5: Disadvantages of Electrospray Ionization (ESI) 30
Table 2.6: Advantages of Matrix-Assisted Laser Desorption/Ionization (MALDI) 32
Table 2.7: Disadvantages of Matrix-Assisted Laser Desorption/Ionization (MALDI)
32
Table 2.8: Mass Analyzers Event 35
Table 2.9: Automated Mass Spectroscopy Platforms for Clinical Laboratory Testing
43
Table 2.10: Companies Marketing Products Using MS Technology Platforms 44
Table 2.11: Mass Spectroscopy Market: Market Drivers Ranked in Order of Impact
45
Table 2.12: Mass Spectroscopy Market: Market Restraints Ranked in Order of
Impact 46
Table 2.13: A Timeline of Mass Spectrometry 47
Table 2.14: Attractive Growth Areas for Mass Spectroscopy Testing 47
Table 3.1: Mass Spectroscopy World Market, 2007-2010 48
Table 3.2: Mass Spectroscopy U.S. Market, 2007-2010 48
Table 3.3: Mass Spectroscopy European Market, 2007-2010 48
Table 3.4: Mass Spectroscopy Japan Market, 2007-2010 49
Table 3.5: Mass Spectroscopy Global Testing Sectors for Forensic and Drug
Testing Market, 2007-2010 49
Table 3.6: Mass Spectroscopy U.S. Testing Sectors for Forensic and Drug Testing
Market, 2007-2010 49
Table 3.7: Mass Spectroscopy European Testing Sectors for Forensic and Drug
Testing Market,
2007-2010 49
Table 3.8: Mass Spectroscopy Japanese Testing Sectors for Forensic and Drug
Testing Market,
2007-2010 49
Table 3.9: Share of Mass Spectroscopy Testing for Life Science, Pharma, and
Clinical by Testing Type,
2010 50
Table 3.10: Key Players and Market Share in Global Mass Spectroscopy Testing
Market 50
Table 3.11: Revenue Model for Mass Spectrometry Testing 51
Table 3.12: Mass Spectroscopy in the Clinical Market: Market Drivers Ranked in
Order of Impact 52
Table 3.13: Mass Spectroscopy in the Clinical Market: Market Restraints Ranked
in Order of Impact 52
Table 3.14: Global Revenue Forecast for Mass Spectroscopy, 2009-2016 53
Table 3.15: U.S. Market Revenue Forecast for Mass Spectroscopy, 2009-2016 54
Table 3.16: European Market Revenue Forecast for Mass Spectroscopy, 2009-2016 55
Table 3.17: Japanese Market Revenue Forecast for Mass Spectroscopy, 2009-2016 56
Table 3.18: Global Revenue Forecast for Mass Spectroscopy Forensic and Drug
Testing Market,
2009-2016 57
Table 3.19: U.S. Market Revenue Forecast for Mass Spectroscopy Forensic and Drug
Testing Market,
2009-2016 59
Table 3.20: European Market Revenue Forecast for Mass Spectroscopy Forensic and
Drug Testing Market,
2009-2015 60
Table 3.21: Japanese Market Revenue Forecast for Mass Spectroscopy Forensic and
Drug Testing Market,
2009-2016 60
Table 3.22: Business Factors Influencing Advanced Mass Spectroscopy Testing
Services 61
Table 3.23: Companies Marketing Multiple Products in Mass Spectroscopy Sector 63
Table 3.24: Commercially Available GC/MS Spectrophotometers 65
Table 3.25: GC/MS Market: Market Drivers Ranked in Order of Impact 66
Table 3.26: GC/MS Market: Market Restraints Ranked in Order of Impact 66
Table 3.27: Commercially Available Ion Trap MS 68
Table 3.28: Commercially Available Liquid Chromatography/MS Systems 74
Table 3.29: Commercially Available Orbitrap MS 80
Table 3.30: Commercially Available MALDI MS 83
Table 3.31: Commercially Available ICP MS 84
Table 4.1: Immunoassays vs. Liquid Chromatography/Mass Spectrometry for Clinical
Analysis 86
Table 4.2: Drugs-of-Abuse and Pain Management 87
Table 4.3: Fastest-Growing Lab Tests, 2006-2009 88
Table 4.4: Therapeutic Drugs 88
Table 4.5: Utilization of Mass Spectrometry for Hormone Analysis 89
Table 4.6: Steroids Commonly Measured Using MS Technology Platforms 91
Table 4.7: Mass Spectroscopy Newborn Screening Program 92
Table 4.8: Prevalence of Metabolic Disorders Analyzed by MS/MS 93
Table 4.9: Principal Cost Factors in the Mass Spectroscopy Clinical Laboratory
Testing Market 95
Table 4.10: Priorities for Vendors 96
Table 4.11: Key Drivers of the Mass Spectroscopy Market in Life Sciences 96
Table 4.12: Proteins Measured in Clinically-available MS Tests in the U.S. 101
Table 4.13: Concentration of Some Abundant Proteins, New Cancer Biomarkers
Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum 106
Table 4.14: Strengths and Limitations of MRM Assays 111
Table 4.15: Software Methods for Mass Spectroscopy for Clinical Analysis 112
Table 4.16: Software Methods for Mass Spectroscopy for Drugs of Abuse Analysis
113
Table 5.1: Technology Trends in Mass Spectroscopy for Clinical Laboratory
Testing 114
Table 5.2: Clinical Testing Trends in Mass Spectroscopy for Clinical Laboratory
Testing 114
Table 5.3: Business Market Trends in Mass Spectroscopy Clinical Laboratory
Testing 115
Table 5.4: Expected Changes in Healthcare 116
Table 5.5: Customer Feedback for Automated Mass Spectroscopy Instruments 116
Table 5.6: Mass Spectroscopy Clinical Laboratory Market: Market Drivers Ranked
in Order of Impact 116
Table 5.7: Mass Spectroscopy Clinical Laboratory Market: Market Restraints
Ranked in Order of Impact 117
Table 5.8: Advantages of European Markets for Mass Spectroscopy Testing 117
Table 5.9: Disadvantages of European Markets for Mass Spectroscopy Testing 117
Table 5.10: Summary of Recent Mandamp;A Activity in the Mass Spectroscopy Sector 120
Table 5.11: High Value Opportunities in Collaborative and Strategic Partnerships
Using MS 121
Table 5.12: Principal Competitive Factors in the Mass Spectroscopy Clinical
Laboratory Testing Market 122
Table 5.13: Mass Spectroscopy Clinical Laboratory Testing Market: Strategic
Recommendations on Mass spectroscopy Sector Business Functions 123
Table 5.14: Mass Spectroscopy Clinical Laboratory Market: Impact of Top Industry
Challenges (U.S.) 123
Table 5.15: Documents for Protecting Intellectual Property Rights 124
Table 5.16: Specific Opportunities for Automated Instrumentation and Reagent
Systems in Mass Spectroscopy for Clinical Laboratory Testing 125
Table 5.17: Strategies and POA for Marketing Clinical Laboratory Diagnostic
Products 133
Table 7.1: Effect of Regulation on Molecular Diagnostics Clinical Laboratory
Market Technology Platforms,
2007-2015 143
Table 7.2: Companies Utilizing New, Cutting-Edge Technologies to Develop,
Validate and Market Mass Spectroscopy Tests for Clinical Use 150
Table 7.3: Impediments to Incorporating Promising Mass Spectroscopy Tests into
Clinical Practice 150
Table 7.4: Alliances Showing the Greatest Synergy in Bringing Mass
Spectroscopy’s Tests to Market 151

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